510(k) K981264 ยท EBF Material, Tooth Shade, Resin
ARISTON PHC
| Applicant | Ivoclar USA, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Jul 2, 1998 |
| Received | Apr 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981264
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.